Download RGUHS M.Pharm 2nd Year 2020 5180 Clinical Research And Pharmacovigilance Question Paper

Download RGUHS (Rajiv Gandhi University of Health Sciences) M.Pharm (Master of Pharmacy) 2nd Year (2nd Semester) 2020 5180 Clinical Research And Pharmacovigilance Previous Question Paper

Rajiv Gandhi University of Health Sciences, Karnataka
Second Semester M. Pharm Degree Examination - 18-Jan-2020
[Time: 3 Hours]
[Max. Marks: 75]
CLINICAL RESEARCH AND PHARMACOVIGILANCE
Q.P. CODE: 5180
Your answers should be specific to the questions asked.
Draw neat, labeled diagrams wherever necessary.
LONG ESSAY (Answer any Three)
3 X 10 = 30 Marks
1.
Explain in detail various phases of clinical trials.
2.
Write the principles of ICH-GCP guidelines.
3.
Explain in detail the process of designing study protocol in clinical trials.
4.
Explain the spontaneous reporting of adverse drug reactions with suitable examples.
Write the merits and demerits of spontaneous reporting. (6+4)
SHORT ESSAY (Answer any Nine)
9 X 5 = 45 Marks
5.
Explain the application of Pharmacoeconomics.
6.
Explain the various measures of outcome in a Pharmacoepidemiological study.
7.
Define Pharmacovigilance. Write in brief in scope of Pharmacovigilance.
8.
Write the role of pharmacist in prevention, monitoring and management of adverse
drug reactions.
9.
Write the composition and responsibilities of Institutional Review Board.
10. Write a note on case control studies.
11. Explain designing of Case Report Form with suitable example.
12. Explain the role of investigators in clinical trials.
13. Define and classify adverse drug reactions with examples.
14. Write a note on VigiFlow.
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